Recall Z-1327-06 ยท CFR Hexokinase, Glucose
Pointe Scientific, Inc.
Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, for the quantitative determination of glucose in serum, 5 x 600 ml R2 glucose HEX, for use with Hitachi analyzer; in vitro diagnostic, Catalog number HG420-R2.
| Date | Aug 3, 2006 (initiated Jun 7, 2006) |
| Status | Terminated |
| Reason | Product does not meet performance specifications through its labeled expiration period. |
| Root cause | Other |
| Action | Customers were notified via recall letter dated 6/7/06 to cease using and to discard these lots, and to send back the recall response form for replacement stocks. |
| Quantity | 13 kits |
| Distribution | Worldwide, including USA, Canada, China, Panama, Russia and Trinidad. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002199 | MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET Pointe Scientific, Inc.,, Nov 20, 2000 |